Enanta's RSV treatment fails Phase 2b study, but positives seen in subgroups
Enanta Pharmaceuticals revealed on Monday that a Phase 2b study for an RSV treatment in high-risk adults missed its primary endpoint. But executives believe there’s a path forward, and investors seem...
View ArticleLarimar's update on Friedreich's ataxia drug derailed by allergic reactions
Larimar Therapeutics' experimental treatment for a rare neuromuscular condition called Friedreich's ataxia showed promising signals of efficacy, but the company also reported several instances of...
View ArticleWhite House deadline brings flurry of pharma price cutdowns
Several drugmakers announced new discounts and direct-to-consumer offerings on Monday as they run up against President Donald Trump’s deadline for pharma companies to bring their US drug prices in line...
View ArticleGenmab CEO on his yearslong interest in Merus
Genmab made one of the splashiest European biopharma acquisitions in recent memory on Monday morning, when it said it would buy antibody maker Merus for $8 billion in cash. Endpoints News caught ...
View ArticleGSK CEO Emma Walmsley on her exit, running the company and more
On Monday, GSK announced that CEO Emma Walmsley will step down and chief commercial officer Luke Miels will replace her. Walmsley joined the company in 2010, ran its consumer division and then ...
View ArticleCDER director says FDA to take 'close look' at use of surrogate endpoints
George Tidmarsh, director of the FDA's drug center, said in a now-deleted social media post that the agency would reconsider the use of surrogate endpoints that have been used to approve drugs more...
View ArticleStar gets $125M Series D as it begins Phase 3 in bleeding disorders
Star Therapeutics patched together a $125 million Series D in what it thinks is pharma's next big therapeutic category. The South San Francisco startup expects the funds to add a few years of runway...
View ArticleOpus says gene therapy for ultra-rare disease boosted vision in teens
Opus Genetics reported that its gene therapy helped partially restore vision in one eye for a small cohort of teens with a rare congenital form of blindness called Leber congenital amaurosis. One of...
View ArticleAnaptysBio plans to split its pipeline from its royalty assets into two...
AnaptysBio wants to split into two companies to see if its pipeline and royalty assets will get more appreciation from investors if they stand alone. The San Diego biotech said Monday ...
View ArticleMetsera’s new obesity data create side effect and efficacy questions for...
Pfizer’s back in obesity. Or is it? The hotly-awaited Phase 2b readout of the long-acting GLP-1 shot developed by Metsera, the biotech Pfizer said it would buy for $4.9 billion last week ...
View ArticleCrystalys lands $205M to bring gout drug first marketed in Japan to the US...
A team that got a gout treatment approved is coming back together to develop a new medicine for the condition in the US and Europe. Crystalys Therapeutics, the San Diego biotech developing the oral...
View ArticleWhite House confirms Section 232 pharma investigation has resulted in 100%...
A White House official confirmed to Endpoints News that President Donald Trump’s social media post which said he'd put 100% tariffs on some branded drugs is a result of the administration's five-month...
View ArticleWalmart takes on wellness
Last Thursday, I stopped by Walmart’s first ever wellness event in swanky Chelsea, Manhattan. Influencers and members of the press milled about, sipping on healthy smoothies, playing pickleball,...
View ArticleMFN updates: Trump drug price announcement on most favored nation
President Donald Trump said Tuesday that Pfizer has agreed to offer all new medicines at “most favored nation” prices, the first drugmaker to make a deal in line with the White House’s push to tie ...
View ArticleBarinthus’ reverse merger with private biotech; Sutro to lay off 33% of...
Plus, news about Ocular Therapeutix, Kardigan, ARS Pharmaceuticals, Full-Life Technologies, Orion, Novo Nordisk, Nxera Pharma and UniQure: 📈 Barinthus Biotherapeutics inks reverse merger: The UK...
View ArticleMerck makes the case for PAH drug Winrevair in patients with earlier disease
Merck's pulmonary arterial hypertension drug Winrevair cut the risk of “clinical worsening” — an endpoint made up of a variety of signs showing that a patient's illness is progressing — by 76% in...
View ArticleUnder new CEO, Novo ends heart failure partnership with Japanese biotech
A small Japanese biotech said it was blindsided by Novo Nordisk’s decision to terminate their work developing a stem cell-based therapy for heart failure. The Danish drug giant ended the collaboration,...
View Article‘Likely’ government shutdown threatens to stress an already depleted FDA
Absent an agreement before midnight, the federal government is headed for a shutdown on Wednesday, potentially leading to tens of thousands of furloughs at HHS and further complicating the work of a...
View ArticleFDA approves Novartis' BTK inhibitor for chronic hives
The FDA on Tuesday approved Novartis' BTK inhibitor to treat patients with chronic spontaneous urticaria, also known as chronic hives. The drug, remibrutinib, will be branded as Rhapsido. It’s the...
View ArticleWhat we do and don’t know after the White House’s deal with Pfizer
The White House heralded its new drug pricing agreement with Pfizer, saying it was prioritizing fairness for American consumers and that it would be the first of many deals struck with drug...
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